Microbion Corporation Receives up to $2.1 million in Funding Support from the US Navy in Partnership with CUBRC, Inc. to Advance Topical Pravibismane

Funding will support exploratory phase 2 proof-of-concept study in patients hospitalized for moderate to severe diabetic foot ulcer infection (DFI)

BOZEMAN, Mont. and VANCOUVER, BC, June 7, 2022 /PRNewswire/ - Microbion Corporation of Bozeman, MT, today announced that it has received non-dilutive funding through its strategic partnership with CUBRC, Inc., a Buffalo-based, independent not-for-profit research company, of up to $2.1 million from the US Navy through the Medical Technology Enterprise Consortium (MTEC) partnership. The funding project is titled "Pravibismane Suspension as a Topical, Broad Spectrum Anti-Infective Wound Care Treatment and Prevention for Combat Injury-Related Infections". The funding received will be used to support the conduct of an exploratory phase 2 proof of concept trial in patients hospitalized for moderate to severe diabetic foot ulcer infection with enrollment expected to begin in Q2 2022.

"We are pleased to be supported by the US Navy and MTEC and are working closely with them to advance our topical pravibismane through phase 2 proof-of-concept studies," said Karim Lalji, CEO of Microbion Pharma Corp. "Our topical diabetic foot ulcer infection program is well aligned to the Navy's interest in innovative wound care technologies to treat and prevent biofilm-related infections, since biofilm contamination is a hallmark characteristic of chronic foot ulcer infections. Further exploration of pravibismane's safety and efficacy in overcoming biofilm-related DFI may potentially expand the clinical utility of topical pravibismane to treat combat wound infections in a variety of settings, including in the field and hospital."

Lester Martinez, MD, MPH, Major General (Retired), U.S. Army, President and Chairman of MTEC Board commented on the importance of Microbion's research. "Though diabetic foot ulcer infections aren't traditionally thought of as a combat related wound suffered in the field, diabetes is a serious disease that affects a significantly high percentage of our veterans and its complications such as DFI contributes to decline in health, quality of life and are responsible for the vast majority of non-combat amputations among veterans. Microbion's research into healing these wounds with the ultimate goal of preventing or delaying amputations can potentially improve the daily lives of these patients and return normal mobility," Dr. Martinez stated.

Pravibismane is the first in a new class of anti-infective drugs structurally unrelated to other clinically utilized antibiotics. With a novel mechanism of action, pravibismane shuts down bacterial ATP production thereby halting global bacterial cellular metabolism. In in vitro studies, pravibismane exhibits broad-spectrum, potent activity against DFI-relevant pathogens and their biofilms including MRSA and drug resistant P. aeruginosa.

In a randomized, double-blind, placebo-controlled Phase 1b trial treating patients with chronic moderate to severe diabetic foot ulcer infection, topical pravibismane treatment plus standard of care demonstrated a numeric 85% wound size reduction versus 30% placebo plus standard of care. Pravibismane also demonstrated a numeric reduction in ulcer-related amputation (2.6% in the pravibismane group vs 15.4% placebo).

DFIs are a major health concern in the Veterans Health Administration as DFUs are associated with a substantial mortality rate (five-year mortality rates are as high as 45% for neuropathic ulcers and 55% for ischemic ulcers¹) and often require amputation to fully address the nidus of infection.² Approximately 28.5 million adults in the US are diagnosed with diabetes, of whom 15 – 25% are at risk of developing a foot ulcer.^3,4 More than half of diabetic foot ulcers become infected.⁵ DFIs remain the most frequent diabetic complication requiring hospitalization and are the most common precipitating event leading to lower extremity amputation.⁶ Furthermore, recent studies suggest that many DFIs are caused by bacteria in a biofilm mode.⁶ In 2018, there were ~8.25 million hospital discharges with diabetes reported, including 154,000 for a lower-extremity amputation.³ US Veterans Affairs estimates there were 20.3 million living Veterans in 2018.⁷ The overall prevalence of diabetes among US veterans is ~25%, which is higher than the US civilian population at ~9%.⁸

1. Del Core MA, Ahn J, Lewis RB, et al. The evaluation and treatment of diabetic foot ulcers and diabetic foot infections. Foot & Ankle Orthopaedics. 2018;3:3. doi:10.1177/2473011418788864
   
   
2. Sundararajan PP, Porter BM, Grant KA, et al. Foot infections in the Veterans Health Administration. The Foot and Ankle Online Journal. 2015;8(3):1. doi:10.3827/faoj.2015.0803.0001
   
   
3. Centers for Disease Control and Prevention. National Diabetes Statistics Report website. https://www.cdc.gov/diabetes/data/statistics-report/index.html, accessed June 6, 2022
   
   
4. Lavery LA, Davis KE, Berriman SJ, et al. WHS guidelines update: Diabetic foot ulcer treatment guidelines. Wound Repair Regen. 2016;24(1):112–26. doi: 10.1111/wrr.12391
   
   
5. Armstrong, DG, Boulton, AJM, and Bus, SA. Diabetic foot ulcers and their recurrence. N Engl J Med.  2017;376:2367-75. doi: 10.1056/NEJMra1615439
   
   
6. Lipsky et al. Guidelines on the diagnosis and treatment of foot infection in persons with diabetes (IWGDF 2019 update). Diab Metab Res Rev. 2020. e3280. doi: 10.1002/dmrr.3280
   
   
7. VETPop2018: A Brief Description. Web: https://www.va.gov/vetdata/docs/Demographics/New_Vetpop_Model/VP_18_A_Brief_Description.pdf, accessed June 6, 2022
   
   
8. Liu Y, Sayam S, Shao X, et al. Prevalence of and trends in diabetes among veterans, United States, 2005–2014. Prev Chronic Dis. 2017;14:170230. doi: 10.5888/pcd14.170230

Microbion is a clinical-stage pharmaceutical company developing a new class of therapeutic compounds to improve the lives of patients with rare and serious diseases. Microbion's lead drug candidate, pravibismane, is the first product in this new class and has a novel mechanism of action offering unique potential to address the unmet needs of chronic and severe health conditions. The Company is advancing inhaled pravibismane in Phase 1 clinical development for the treatment of chronic lung diseases, including non-tuberculous mycobacteria (NTM) and cystic fibrosis-related lung infections. Topical/local pravibismane is in Phase 2 development for the treatment of chronic wounds and orthopedic infections. Pravibismane has received backing from the Cystic Fibrosis Foundation, NIH, US DoD, and CARB-X with over $21 million in grants. The FDA has granted pravibismane with Orphan Drug, Fast Track, and QIDP designations. Microbion Pharma Corp. is a wholly owned subsidiary of Microbion Corporation. For more information visit: www.microbioncorp.com.

CUBRC is an independent not-for-profit scientific corporation that executes Research, Development, Testing and Systems Integration programs in Medical Sciences, Chemical and Biological Defense, Data Science and Information Fusion, Command and Control, and Hypersonics.  For more information visit: www.cubrc.org.

Certain of the statements made in this press release are forward-looking, such as those, among others, relating to the success of clinical development of pravibismane and preparation for potential commercialization. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: our ability to enroll patients in our clinical trials at the pace that we project; the size and growth of the potential markets for pravibismane or any future product candidates and our ability to serve those markets; our ability to obtain and maintain regulatory approval of pravibismane or any future product candidates; and our expectations regarding the potential safety, efficacy or clinical utility of pravibismane or any future product candidates. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Microbion Corporation disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Efforts described herein were partially sponsored by the Government under Other Transactions Number W81XWH-15-9-0001. The U.S. Government is authorized to reproduce and distribute reprints for Governmental purposes notwithstanding any copyright notation thereon.  The views and conclusions contained herein are those of the authors and should not be interpreted as necessarily representing the official policies or endorsements, either expressed or implied, of the U.S. Government.

SOURCE Microbion Corporation